Clinical Trial: Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor.
Detailed Summary:
OBJECTIVES:
- Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at first progression.
- Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory medulloblastoma at second or later relapse.
- Estimate the objective response rate to oxaliplatin in pediatric patients with recurrent or refractory supratentorial primitive neuroectodermal tumor, or atypical teratoid rhabdoid tumor.
- Describe the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (medulloblastoma [measurable disease at first relapse vs positive cerebrospinal fluid or linear leptomeningeal disease vs measurable disease at second or later progression] vs supratentorial primitive neuroectodermal tumor vs atypical teratoid rhabdoid tumor).
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses (1 year) in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 1.5-2.8 years.
Sponsor: Pediatric Brain Tumor Consortium
Current Primary Outcome:
- Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression
- Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse
Original Primary Outcome:
Current Secondary Outcome:
- Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT)
- Pharmacokinetics of oxaliplatin in the serum and CSF
Original Secondary Outcome:
Information By: Pediatric Brain Tumor Consortium
Dates:
Date Received: October 3, 2002
Date Started: October 2002
Date Completion:
Last Updated: October 14, 2009
Last Verified: October 2009